Insertion mechanism for a drug delivery pump

ABSTRACT

An insertion mechanism for a drug pump includes an insertion mechanism housing; a manifold guide; an insertion biasing members initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the manifold guide; and a manifold having a septum and a cannula, wherein the annular space between the septum and the cannula defines a manifold header. The needle and cannula are inserted into the body of a user by the insertion biasing member(s), after which only the needle is retracted. Retraction of the needle may open a fluid pathway from the manifold header to the body through the cannula. A drug delivery pump includes an activation mechanism, a drive mechanism, a fluid pathway connection, and the insertion mechanism. Assembly and operation methods are provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/599,727, filed Aug. 30, 2012, which claims priority to U.S.Provisional Application No. 61/530,774, filed on Sep. 2, 2011, each ofwhich is included by reference herein in its entirety for all purposes.

FIELD

THIS INVENTION relates to drug delivery pumps. More particularly, thisinvention relates to insertion mechanisms for drug delivery pumps, drugdelivery pumps with safety integrated insertion mechanisms, the methodsof operating such devices, and the methods of assembling such devices.

BACKGROUND

Parenteral delivery of various drugs, i.e., delivery by means other thanthrough the digestive track, has become a desired method of drugdelivery for a number of reasons. This form of drug delivery byinjection may enhance the effect of the substance being delivered andensure that the unaltered medicine reaches its intended site at asignificant concentration. Similarly, undesired side effects associatedwith other routes of delivery, such as systemic toxicity, canpotentially be avoided through parenteral delivery. By bypassing thedigestive system of a mammalian patient, one can avoid degradation ofthe active ingredients caused by the catalytic enzymes in the digestivetract and liver and ensure that a necessary amount of drug, at a desiredconcentration, reaches the targeted site.

Traditionally, manually operated syringes and injection pens have beenemployed for delivering parenteral drugs to a patient. More recently,parenteral delivery of liquid medicines into the body has beenaccomplished by administering bolus injections using a needle andreservoir, continuously by gravity driven dispensers, or via transdermalpatch technologies. Bolus injections often imperfectly match theclinical needs of the patient, and usually require larger individualdoses than are desired at the specific time they are given. Continuousdelivery of medicine through gravity-feed systems compromises thepatient's mobility and lifestyle, and limits the therapy to simplisticflow rates and profiles. Another form of drug delivery, transdermalpatches, similarly has its restrictions. Transdermal patches oftenrequire specific molecular drug structures for efficacy, and the controlof the drug administration through a transdermal patch is severelylimited.

Ambulatory infusion pumps have been developed for delivering liquidmedicaments to a patient. These infusion devices have the ability tooffer sophisticated fluid delivery profiles accomplishing bolusrequirements, continuous infusion and variable flow rate delivery. Theseinfusion capabilities usually result in better efficacy of the drug andtherapy and less toxicity to the patient's system. Currently availableambulatory infusion devices are expensive, difficult to program andprepare for infusion, and tend to be bulky, heavy and very fragile.Filling these devices can be difficult and require the patient to carryboth the intended medication as well as filling accessories. The devicesoften require specialized care, maintenance, and cleaning to assureproper functionality and safety for their intended long-term use, andare not cost-effective for patients or healthcare providers.

As compared to syringes and injection pens, pump type delivery devicescan be significantly more convenient to a patient, in that doses of thedrug may be calculated and delivered automatically to a patient at anytime during the day or night. Furthermore, when used in conjunction withmetabolic sensors or monitors, pumps may be automatically controlled toprovide appropriate doses of a fluidic medium at appropriate times ofneed, based on sensed or monitored metabolic levels. As a result, pumptype delivery devices have become an important aspect of modern medicaltreatments of various types of medical conditions, such as diabetes, andthe like.

While pump type delivery systems have been utilized to solve a number ofpatient needs, manually operated syringes and injection pens oftenremain a preferred choice for drug delivery as they now provideintegrated safety features and can easily be read to identify the statusof drug delivery and the end of dose dispensing. However, manuallyoperated syringes and injections pens are not universally applicable andare not preferred for delivery of all drugs. There remains a need for anadjustable (and/or programmable) infusion system that is precise andreliable and can offer clinicians and patients a small, low cost, lightweight, simple to use alternative for parenteral delivery of liquidmedicines.

SUMMARY

The present invention provides insertion mechanisms for drug deliverypumps, drug delivery pumps with safety integrated insertion mechanisms,the methods of operating such devices, and the methods of assemblingsuch devices. The insertion mechanisms of the present invention provideintegrated safety features which automatically retract the needle intothe device while retaining the cannula within the body of the user to,for example, minimize pain and discomfort associated with drug delivery.Additionally, the embodiments of the present invention provide sterilefluid pathways through the novel insertion mechanisms and drug pumps,which pathways are only engaged, connected, or opened upon properactivation by the user. Accordingly, the novel devices of the presentinvention alleviate one or more of the problems associated with priorart devices, such as those referred to above.

In a first embodiment, the present invention provides an insertionmechanism for a drug pump, said insertion mechanism including: aninsertion mechanism housing having an internal chamber; a manifold guidehaving an upper chamber and a lower chamber separated by a manifoldguide ring; one or more insertion biasing members initially held in anenergized state within the internal chamber of insertion mechanismhousing between the housing and the manifold guide ring; a clip flexiblyengaged with the upper chamber of the manifold guide; a retractionbiasing member and a hub connected to a proximal end of a needle,wherein the retraction biasing member is held initially in an energizedstate between the hub and the manifold guide; and a manifold having aseptum and a cannula, wherein the annular space between the septum andthe cannula defines a manifold header. In an alternative embodiment, theinsertion mechanism may include two or more insertion biasing members.The manifold has a manifold intake for connection to a fluid conduit.

The insertion mechanism may further include a base connected to a distalend of the insertion mechanism housing. A sterile boot may be fixedlyconnected between the manifold and the base connected to a distal end ofthe insertion mechanism housing. The term “sterile boot” is used todescribe a boot within which certain internal components may reside, atone or more stages of operation, in a sterile condition. The boot neednot be sterile through the entire operation of the mechanism or pumpand, in fact, may not be initially sterile until assembly andsterilization of certain components has occurred. Additionally, the term“boot” is not intended to mean any specific shape or configuration, butis instead utilized to describe a component that can provide an interiorspace within which other components may reside at one or more stages ofoperation. One or more guide protrusions may extend from a proximal endof the insertion mechanism housing into the internal chamber.Alternatively, the one or more guide protrusions may be a separatecomponent that is fixed to the insertion mechanism housing. The manifoldguide ring has one or more pass-throughs which correspond with the guideprotrusions, wherein the manifold guide is slidably engaged with thehousing by interaction between the pass-throughs and the guideprotrusions. The interaction between the pass-throughs and the guideprotrusions may also function to maintain the rotational alignment ofthe manifold guide and/or to promote proper assembly of the components.The insertion mechanism may further include a ferrule which maintainsthe cannula in a fixed and sealed position within the manifold.

The clip may have one or more arms, with each arm having a releasesurface and a lockout surface. In an initial locked configuration therelease surfaces engage the hub to maintain the retraction biasingmember in an energized state; and, in a retracted configuration therelease surfaces disengage the hub to permit de-energizing of theretraction biasing member, thereby retracting the hub and the needle. Inthe retracted configuration, the cannula is maintained in the insertedposition within the body of the user by the fixed and/or sealed manifoldconnection enabled by the ferrule. The cannula, manifold, and manifoldguide are maintained in their final positions and prevented from axialtranslation in the proximal direction by interaction between the lockoutsurfaces of the clips and the distal ends of the guide protrusions,effectively locking out further motion of these components.

In another embodiment, the present invention provides a drug deliverypump with integrated safety features includes a housing and an assemblyplatform, upon which an activation mechanism, a drive mechanism, a fluidpathway connection, a power control system, and an insertion mechanismfor a drug pump may be mounted, said insertion mechanism including: aninsertion mechanism housing having an internal chamber; a manifold guidehaving an upper chamber and a lower chamber separated by a manifoldguide ring; one or more insertion biasing members initially held in anenergized state within the internal chamber of insertion mechanismhousing between the housing and the manifold guide ring; a clip flexiblyengaged with the upper chamber of the manifold guide; a retractionbiasing member and a hub connected to a proximal end of a needle,wherein the retraction biasing member is held initially in an energizedstate between the hub and the manifold guide; a manifold having a septumand a cannula, wherein the annular space between the septum and thecannula defines a manifold header; and a base for connection of theinsertion mechanism to the assembly platform.

The insertion mechanism of the drug pump may further include a baseconnected to a distal end of the insertion mechanism housing. Themanifold may have a manifold intake for connection to a fluid conduit,wherein the fluid conduit is employable for fluid transfer between thefluid pathway connection and the insertion mechanism. A sterile boot maybe fixedly connected between the manifold and the base connected to adistal end of the insertion mechanism housing. These components functionto maintain the sterility of the fluid pathway, the needle, and thecannula prior to insertion into the body of the user. Retraction of theneedle from the cannula, as described further herein, may be utilized toopen a fluid pathway from the manifold header through the cannula to thebody of the user.

In a further embodiment, the present invention provides a method ofassembling the insertion mechanism includes the steps of: connecting ahub to a proximal end of a needle; inserting the hub and needle into aninner upper chamber of a manifold guide, wherein a retraction biasingmember is maintained in an energized state between the manifold guideand the hub, and maintained in the energized state by a clip fixedly andflexibly connected to the manifold guide at a clip interface. The methodfurther includes: inserting a cannula into a manifold and inserting aseptum into the manifold at an end opposing the cannula to create amanifold header there-between, and subsequently inserting the manifold,septum, and cannula into a lower chamber of the manifold guide such thatthe needle pierces through the septum and resides initially at leastpartially within the cannula. Furthermore, the method includes:inserting an insertion biasing member into an insertion mechanismhousing between the housing and one or more guide protrusions extendinginto the interior of the housing from a proximal end; inserting themanifold guide into the insertion mechanism housing such that the guideprotrusions extend through corresponding pass-throughs on a manifoldguide ring aspect of the manifold guide, wherein as the manifold guideis translated in the proximal direction, the insertion biasing member iscaused to contact the manifold guide ring and become energized.

Upon translation of the manifold guide and compression of the insertionbiasing member to a point above one or more lockout windows of theinsertion mechanism housing, the method includes the step of: placingone or more corresponding lockout pin(s) into the lockout windows and inremovable engagement with the manifold guide to retain the manifoldguide in this position and the insertion biasing member in the energizedstate. Finally, a base may be attached to the distal end of theinsertion mechanism housing to maintain the components in position. Themethod of assembly may further include the step of: attaching a sterileboot in fixed engagement at a proximal end to the manifold and in afixed engagement at a distal end to the base. Similarly, the method mayinclude: attaching a fluid conduit to the manifold at a manifold intake.

In yet another embodiment, the present invention provides a method ofoperating the drug delivery pump. The method of operation includes:displacing an activation mechanism to disengage one or more lockout pinsfrom corresponding lockout windows of an insertion mechanism housing,wherein such disengagement permits an insertion biasing member to expandin a distal direction substantially along a longitudinal axis of theinsertion mechanism housing from its initial energized state, whereinsuch expansion drives insertion of a needle and a cannula into the bodyof a user. The method further includes: disengaging one or more releasesurfaces of a clip from engagement with a hub retained within a manifoldguide within the insertion mechanism housing, wherein such disengagementpermits a retraction biasing member to expand in a proximal directionsubstantially along a longitudinal axis of the insertion mechanismhousing from its initial energized state, wherein such expansion drivesretraction of the needle while retaining the cannula into the body of auser; connecting a fluid pathway connection having a piercing member toa drug container having a pierceable seal; and activating a drivemechanism to force a fluid through the fluid pathway connection, thecannula, and into the body of a user. In a preferred embodiment, themethod of operation may include: first displacing one or more on-bodysensors to permit displacement of the activation mechanism. Retractionof the needle from the cannula opens a fluid pathway from the fluidpathway connection to the cannula, for delivery of a drug fluid to thebody of a user.

Throughout this specification, unless otherwise indicated, “comprise,”“comprises,” and “comprising,” or related terms such as “includes” or“consists of,” are used inclusively rather than exclusively, so that astated integer or group of integers may include one or more othernon-stated integers or groups of integers. As will be described furtherbelow, the embodiments of the present invention may include one or moreadditional components which may be considered standard components in theindustry of medical devices. The components, and the embodimentscontaining such components, are within the contemplation of the presentinvention and are to be understood as falling within the breadth andscope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following non-limiting embodiments of the invention are describedherein with reference to the following drawings, wherein:

FIG. 1A shows an isometric view of a drug delivery pump having safetyintegrated insertion mechanisms, according to one embodiment of thepresent invention;

FIG. 1B shows an isometric view of the interior components of the drugdelivery pump shown in FIG. 1A;

FIG. 1C shows an isometric view of the bottom of the drug delivery pumpshown in FIG. 1A;

FIG. 2A shows an isometric view of an insertion mechanism, according toa first embodiment of the present invention;

FIG. 2B shows an isometric view of an insertion mechanism, according toanother embodiment of the present invention;

FIG. 3A shows an exploded view, exploded along an axis “A,” of theinsertion mechanism shown in FIG. 2A;

FIG. 3B shows a cross-sectional exploded view, exploded along an axis“A,” of the insertion mechanism shown in FIG. 2A;

FIG. 4 shows a cross-section isometric view of the insertion mechanismhousing and manifold guide of the insertion mechanism, according to afirst embodiment of the present invention;

FIG. 5A shows an isometric view of a clip of the insertion mechanism,according to a first embodiment of the present invention;

FIG. 5B shows an isometric view of the manifold guide shown in FIG. 4;

FIG. 5C shows an isometric view of a manifold, a manifold intake, and afluid conduit of the insertion mechanism, according to a firstembodiment of the present invention;

FIG. 6A shows a cross-sectional view of an insertion mechanism,according to a first embodiment of the present invention, in a lockedand ready to use stage;

FIG. 6B shows a cross-sectional view of an insertion mechanism,according to a first embodiment of the present invention, in an unlockedand inserted stage; and

FIG. 6C shows a cross-sectional view of an insertion mechanism,according to a first embodiment of the present invention, in a retractedstage for drug delivery.

DETAILED DESCRIPTION

As used herein to describe the insertion mechanisms, drug deliverypumps, or any of the relative positions of the components of the presentinvention, the terms “axial” or “axially” refer generally to alongitudinal axis “A” around which the insertion mechanisms arepreferably positioned, although not necessarily symmetricallythere-around. The term “radial” refers generally to a direction normalto axis A. The terms “proximal,” “rear,” “rearward,” “back,” or“backward” refer generally to an axial direction in the direction “P”.The terms “distal,” “front,” “frontward,” “depressed,” or “forward”refer generally to an axial direction in the direction “D”. As usedherein, the term “glass” should be understood to include other similarlynon-reactive materials suitable for use in a pharmaceutical gradeapplication that would normally require glass, including but not limitedto certain non-reactive polymers such as cyclic olefin copolymers (COC)and cyclic olefin polymers (COP). The term “plastic” may include boththermoplastic and thermosetting polymers. Thermoplastic polymers can bere-softened to their original condition by heat; thermosetting polymerscannot. As used herein, the term “plastic” refers primarily to moldablethermoplastic polymers such as, for example, polyethylene andpolypropylene, or an acrylic resin, that also typically contain otheringredients such as curatives, fillers, reinforcing agents, colorants,and/or plasticizers, etc., and that can be formed or molded under heatand pressure. As used herein, the term “plastic” is not meant to includeglass, non-reactive polymers, or elastomers that are approved for use inapplications where they are in direct contact with therapeutic liquidsthat can interact with plastic or that can be degraded by substituentsthat could otherwise enter the liquid from plastic. The term“elastomer,” “elastomeric” or “elastomeric material” refers primarily tocross-linked thermosetting rubbery polymers that are more easilydeformable than plastics but that are approved for use withpharmaceutical grade fluids and are not readily susceptible to leachingor gas migration under ambient temperature and pressure. “Fluid” refersprimarily to liquids, but can also include suspensions of solidsdispersed in liquids, and gasses dissolved in or otherwise presenttogether within liquids inside the fluid-containing portions ofsyringes. According to various aspects and embodiments described herein,reference is made to a “biasing member”, such as in the context of oneor more biasing members for insertion or retraction of the needle,trocar, and/or cannula. It will be appreciated that the biasing membermay be any member that is capable of storing and releasing energy.Non-limiting examples include a spring, such as for example a coiledspring, a compression or extension spring, a torsional spring, and aleaf spring, a resiliently compressible or elastic band, or any othermember with similar functions. In at least one embodiment of the presentinvention, the biasing member is a spring, preferably a compressionspring.

The novel devices of the present invention provide insertion mechanismswith integrated safety features and drug delivery pumps whichincorporate such insertion mechanisms. Such devices are safe and easy touse, and are aesthetically and ergonomically appealing forself-administering patients. The devices described herein incorporatefeatures which make activation, operation, and lock-out of the devicesimple for even untrained users. The novel devices of the presentinvention provide these desirable features without any of the problemsassociated with known prior art devices. Certain non-limitingembodiments of the novel drug delivery pump, insertion mechanism, andtheir respective components are described further herein with referenceto the accompanying figures.

Drug Delivery Pump:

As used herein, the term “pump” is intended to include any number ofdrug delivery systems which are capable of dispensing a fluid to a userupon activation. Such drug delivery systems include, for example,injection systems, infusion pumps, bolus injectors, and the like. FIGS.1A-1C show an exemplary drug delivery device according to at least oneembodiment of the present invention. The drug delivery device may beutilized to administer delivery of a drug treatment into a body of auser. As shown in FIGS. 1A-1C, the drug pump 10 includes a pump housing12. Pump housing 12 may include one or more housing subcomponents whichare fixedly engageable to facilitate easier manufacturing, assembly, andoperation of the drug pump. For example, drug pump 10 includes a pumphousing 12 which includes an upper housing 12A and a lower housing 12B.The drug pump may further include an activation mechanism 14, a statusindicator 16, and a window 18. Window 18 may be any translucent ortransmissive surface through which the operation of the drug pump may beviewed. As shown in FIG. 1B, drug pump further includes assemblyplatform 20, sterile fluid conduit 30, drive mechanism 100 having drugcontainer 50, insertion mechanism 200, fluid pathway connection 300, andpower and control system 400. One or more of the components of such drugpumps may be modular in that they may be, for example, pre-assembled asseparate components and configured into position onto the assemblyplatform 20 of the drug pump 10 during manufacturing.

The pump housing 12 contains all of the device components and provides ameans of removably attaching the device 10 to the skin of the user. Thepump housing 12 also provides protection to the interior components ofthe device 10 against environmental influences. The pump housing 12 isergonomically and aesthetically designed in size, shape, and relatedfeatures to facilitate easy packaging, storage, handling, and use byusers who may be untrained and/or physically impaired. Furthermore, theexternal surface of the pump housing 12 may be utilized to provideproduct labeling, safety instructions, and the like. Additionally, asdescribed above, housing 12 may include certain components, such asstatus indicator 16 and window 18, which may provide operation feedbackto the user.

In at least one embodiment, the drug pump 10 provides an activationmechanism 14 that is displaced by the user to trigger the start commandto the power and control system 400. In a preferred embodiment, theactivation mechanism is a start button 14 that is located through thepump housing 12, such as through an aperture between upper housing 12Aand lower housing 12B, and which contacts a control arm 40 of the powerand control system 400. In at least one embodiment, the start button 14may be a push button, and in other embodiments, may be an on/off switch,a toggle, or any similar activation feature known in the art. The pumphousing 12 also provides a status indicator 16 and a window 18. In otherembodiments, one or more of the activation mechanism 14, the statusindicator 16, the window 18, and combinations thereof may be provided onthe upper housing 12A or the lower housing 12B such as, for example, ona side visible to the user when the drug pump 10 is placed on the bodyof the user. Housing 12 is described in further detail hereinafter withreference to other components and embodiments of the present invention.

Drug pump is configured such that, upon activation by a user bydepression of the activation mechanism, the drug pump is initiated to:insert a fluid pathway into the user; enable, connect, or open necessaryconnections between a drug container, a fluid pathway, and a sterilefluid conduit; and force drug fluid stored in the drug container throughthe fluid pathway and fluid conduit for delivery into a user. One ormore optional safety mechanisms may be utilized, for example, to preventpremature activation of the drug pump. For example, an optional on-bodysensor 24 (shown in FIG. 1C) may be provided in one embodiment as asafety feature to ensure that the power and control system 400, or theactivation mechanism, cannot be engaged unless the drug pump 10 is incontact with the body of the user. In one such embodiment, the on-bodysensor 24 is located on the bottom of lower housing 12B where it maycome in contact with the user's body. Upon displacement of the on-bodysensor 24, depression of the activation mechanism is permitted.Accordingly, in at least one embodiment the on-body sensor 24 is amechanical safety mechanism, such as for example a mechanical lock out,that prevents triggering of the drug pump 10 by the activation mechanism14. In another embodiment, the on-body sensor may be anelectro-mechanical sensor such as a mechanical lock out that sends asignal to the power and control system 400 to permit activation. Instill other embodiments, the on-body sensor can be electrically basedsuch as, for example, a capacitive- or impedance-based sensor which mustdetect tissue before permitting activation of the power and controlsystem 400. These concepts are not mutually exclusive and one or morecombinations may be utilized within the breadth of the present inventionto prevent, for example, premature activation of the drug pump. In apreferred embodiment, the drug pump 10 utilizes one or more mechanicalon-body sensors. Additional integrated safety mechanisms are describedherein with reference to other components of the novel drug pumps.

Power and Control System:

The power and control system 400 includes a power source, which providesthe energy for various electrical components within the drug pump, oneor more feedback mechanisms, a microcontroller, a circuit board, one ormore conductive pads, and one or more interconnects. Other componentscommonly used in such electrical systems may also be included, as wouldbe appreciated by one having ordinary skill in the art. The one or morefeedback mechanisms may include, for example, audible alarms such aspiezo alarms and/or light indicators such as light emitting diodes(LEDs). The microcontroller may be, for example, a microprocessor. Thepower and control system 400 controls several device interactions withthe user and interfaces with the drive mechanism 100. In one embodiment,the power and control system 400 interfaces with the control arm 40 toidentify when the on-body sensor 24 and/or the activation mechanism 14have been activated. The power and control system 400 may also interfacewith the status indicator 16 of the pump housing 12, which may be atransmissive or translucent material which permits light transfer, toprovide visual feedback to the user. The power and control system 400interfaces with the drive mechanism 100 through one or moreinterconnects to relay status indication, such as activation, drugdelivery, and end-of-dose, to the user. Such status indication may bepresented to the user via auditory tones, such as through the audiblealarms, and/or via visual indicators, such as through the LEDs. In apreferred embodiment, the control interfaces between the power andcontrol system and the other components of the drug pump are not engagedor connected until activation by the user. This is a desirable safetyfeature that prevents accidental operation of the drug pump and mayadditionally maintain the energy contained in the power source duringstorage, transportation, and the like.

The power and control system 400 may be configured to provide a numberof different status indicators to the user. For example, the power andcontrol system 400 may be configured such that after the on-body sensorand/or trigger mechanism have been pressed, the power and control system400 provides a ready-to-start status signal via the status indicator 16if device start-up checks provide no errors. After providing theready-to-start status signal and, in an embodiment with the optionalon-body sensor, if the on-body sensor remains in contact with the bodyof the user, the power and control system 400 will power the drivemechanism 100 to begin delivery of the drug treatment through the fluidpathway connection 300 and sterile fluid conduit 30. In a preferredembodiment of the present invention, the insertion mechanism 200 and thefluid pathway connection 300 may be caused to activate directly by useroperation of the activation mechanism 14. During the drug deliveryprocess, the power and control system 400 is configured to provide adispensing status signal via the status indicator 16. After the drug hasbeen administered into the body of the user and after the end of anyadditional dwell time, to ensure that substantially the entire dose hasbeen delivered to the user, the power and control system 400 may providean okay-to-remove status signal via the status indicator 16. This may beindependently verified by the user by viewing the drive mechanism anddrug dose delivery through the window 18 of the pump housing 12.Additionally, the power and control system 400 may be configured toprovide one or more alert signals via the status indicator 16, such asfor example alerts indicative of fault or operation failure situations.

Other power and control system configurations may be utilized with thenovel drug pumps of the present invention. For example, certainactivation delays may be utilized during drug delivery. As mentionedabove, one such delay optionally included within the systemconfiguration is a dwell time which ensures that substantially theentire drug dose has been delivered before signaling completion to theuser. Similarly, activation of the device may require a delayeddepression (i.e., pushing) of the activation mechanism 14 of the drugpump 10 prior to drug pump activation. Additionally, the system mayinclude a feature which permits the user to respond to the end-of-dosesignals and to deactivate or power-down the drug pump. Such a featuremay similarly require a delayed depression of the activation mechanism,to prevent accidental deactivation of the device. Such features providedesirable safety integration and ease-of-use parameters to the drugpumps. An additional safety feature may be integrated into theactivation mechanism to prevent partial depression and, therefore,partial activation of the drug pumps. For example, the activationmechanism and/or power and control system may be configured such thatthe device is either completely off or completely on, to prevent partialactivation. Such features are described in further detail hereinafterwith regard to other aspects of the novel drug pumps.

Fluid Pathway Connection:

The fluid pathway connection 300 includes a sterile fluid conduit 30, apiercing member, a connection hub, and a sterile sleeve. The fluidpathway connection may further include one or more flow restrictors.Upon proper activation of the device 10, the fluid pathway connection300 is enabled to connect the sterile fluid conduit 30 to the drugcontainer of the drive mechanism 100. Such connection may be facilitatedby a piercing member, such as a needle, penetrating a pierceable seal ofthe drug container of the drive mechanism 100. The sterility of thisconnection may be maintained by performing the connection within aflexible sterile sleeve. Upon substantially simultaneous activation ofthe insertion mechanism, the fluid pathway between drug container andinsertion mechanism is complete to permit drug delivery into the body ofthe user.

In at least one embodiment of the present invention, the piercing memberof the fluid pathway connection is caused to penetrate the pierceableseal of the drug container of the drive mechanism by direct action ofthe user, such as by depression of the activation mechanism by the user.For example, the activation mechanism itself may bear on the fluidpathway connection such that displacement of the activation mechanismfrom its original position also causes displacement of the fluid pathwayconnection. In a preferred embodiment, this connection is enabled by theuser depressing the activation mechanism and, thereby, driving thepiercing member through the pierceable seal, because this prevents fluidflow from the drug container until desired by the user. In such anembodiment, a compressible sterile sleeve may be fixedly attachedbetween the cap of the drug container and the connection hub of thefluid pathway connection. The piercing member may reside within thesterile sleeve until a connection between the fluid connection pathwayand the drug container is desired. The sterile sleeve may be sterilizedto ensure the sterility of the piercing member and the fluid pathwayprior to activation.

The drug pump is capable of delivering a range of drugs with differentviscosities and volumes. The drug pump is capable of delivering a drugat a controlled flow rate (speed) and/or of a specified volume. In oneembodiment, the drug delivery process is controlled by one or more flowrestrictors within the fluid pathway connection and/or the sterile fluidconduit. In other embodiments, other flow rates may be provided byvarying the geometry of the fluid flow path or delivery conduit, varyingthe speed at which a component of the drive mechanism advances into thedrug container to dispense the drug therein, or combinations thereof.Still further details about the fluid pathway connection 300 and thesterile fluid conduit 30 are provided hereinafter in later sections inreference to other embodiments.

Drive Mechanism:

The drive mechanism 100 includes drug container 50 having a cap, apierceable seal, and a plunger seal. The drug container may contain adrug fluid, within the container between the cap and the plunger seal,for delivery through the insertion mechanism and drug pump into the bodyof the user. The drive mechanism may further include one or more drivebiasing members, one or more release mechanisms, and one or more guides.The components of the drive mechanism function to force a fluid from thedrug container out through the pierceable seal or, preferably, throughthe piercing member of the fluid pathway connection for delivery throughthe fluid pathway connection, sterile fluid conduit, and insertionmechanism into the body of the user.

The drive mechanism may further include one or more electrical contactslocated on corresponding components which, upon contact betweenelectrical contacts, are capable of continuing an energy pathway orotherwise relay a signal to and/or from the power and control system400. Such signals may be transferred across one or more interconnects.Such components may be utilized within the drive mechanism to measureand relay information related to the status of operation of the drivemechanism, which may be converted by the power and control system 400into tactile, auditory, and/or visual feedback to the user.

In one particular embodiment, the drive mechanism 100 employs one ormore compression springs as the biasing member(s). Upon activation ofthe drug pump by the user, the power and control system may be actuatedto directly or indirectly release the compression spring(s) from anenergized state. Upon release, the compression spring(s) may bearagainst and act upon the plunger seal to force the fluid drug out of thedrug container. The fluid pathway connection is connected through thepierceable seal prior to, concurrently with, or after activation of thedrive mechanism to permit fluid flow from the drug container, throughthe fluid pathway connection, sterile fluid conduit, and insertionmechanism, and into the body of the user for drug delivery. In at leastone embodiment, the fluid flows through only a manifold and a cannula ofthe insertion mechanism, thereby maintaining the sterility of the fluidpathway before and during drug delivery. Such components and theirfunctions are described in further detail hereinafter.

Insertion Mechanism:

The insertion mechanism 200 includes an insertion mechanism housing 202having one or more lockout windows 202A, a base 252, and a sterile boot250, as shown in FIG. 2A. Base 252 may be connected to assembly platform20 to integrate the insertion mechanism into the drug pump 10 (as shownin FIG. 1B). The connection of the base 252 to the assembly platform 20may be, for example, such that the bottom of the base is permitted topass-through a hole in the assembly platform to permit direct contact ofthe base to the body of the user. In such configurations, the bottom ofthe base 252 may include a sealing membrane 254 that, at least in oneembodiment, is removable prior to use of the drug pump 10.Alternatively, the sealing membrane 254 may remain attached to thebottom of the base 252 such that the needle 214 pierces the sealingmembrane 254 during operation of the drug pump 10. As shown in FIGS. 3Aand 3B, the insertion mechanism 200 may further include an insertionbiasing member 210, a hub 212, a needle 214, a retraction biasing member216, a clip 218, a manifold guide 220, a septum 230, a cannula 234, anda manifold 240. The manifold 240 may connect to sterile fluid conduit 30to permit fluid flow through the manifold 240, cannula 234, and into thebody of the user during drug delivery, as will be described in furtherdetail herein.

The manifold guide 220 may include an upper chamber 222 and a lowerchamber 226 separated by a manifold guide ring 228. The upper chamber222 may include a clip interface slot 220A for engageable retention ofclip 218. The upper chamber 222 may have an inner upper chamber 222A,within which the retraction biasing member 216, the clip 218, and thehub 212 may reside during an initial locked stage of operation, and anouter upper chamber 222B, which interfaces with the insertion biasingmember 210. In at least one embodiment, the insertion biasing member 210and the retraction biasing member 216 are springs, preferablycompression springs. The hub 212 may be engageably connected to aproximal end of needle 214, such that displacement or axial translationof the hub 212 causes related motion of the needle 214.

As used herein, “needle” is intended to refer to a variety of needlesincluding but not limited to conventional hollow needles, such as arigid hollow steel needles, and solid core needles more commonlyreferred to as a “trocars.” In a preferred embodiment, the needle is a27 gauge solid core trocar and in other embodiments, the needle may beany size needle suitable to insert the cannula for the type of drug anddrug administration (e.g., subcutaneous, intramuscular, intradermal,etc.) intended. Upon assembly, the proximal end of needle 214 ismaintained in fixed contact with hub 212, while the remainder of needle214 is permitted to pass-through retraction biasing member 216, anaperture 218C of clip 218 (shown in FIG. 5A), and manifold guide 220.The needle 214 may further pass-through septum 230, cannula 234,manifold 240 through manifold header 242, sterile boot 250, and base 252through base opening 252A. Septum 230, cannula 234, and manifold 240 mayreside within lower chamber 226 of manifold guide 220 and within sterileboot 250 until operation of the insertion mechanism. In this position,the cannula 234 may reside over a distal portion of the needle 214 andheld in place within the manifold header 242 of manifold 240 by aferrule 232. Ferrule 232 ensures that cannula 234 remains substantiallyfixed and in sealed engagement within the manifold 240 to, for example,maintain the sterility of the manifold header 242. Similarly, septum 230resides substantially fixed and in sealed engagement within the upperportion of the manifold 240 to maintain the sterility of the manifoldheader 242.

Sterile boot 250 is a collapsible or compressible sterile membrane thatis in fixed engagement at a proximal end with the manifold 240 and at adistal end with the base 252. In at least on embodiment, the sterileboot 250 is maintained in fixed engagement at a distal end between base252 and insertion mechanism housing 202, as shown in FIGS. 6A-6C. Base252 includes a base opening 252A through which the needle and cannulamay pass-through during operation of the insertion mechanism, as will bedescribed further below. Sterility of the cannula and needle aremaintained by their initial positioning within the sterile portions ofthe insertion mechanism. Specifically, as described above, needle 214and cannula 234 are maintained in the sterile environment of themanifold header 242 and sterile boot 250. The base opening 252A of base252 may be closed from non-sterile environments as well, such as by forexample a sealing membrane 254.

FIGS. 3A-3B, 4, and 5A-5C show the components of the insertionmechanism, according to at least a first embodiment, in greater detail.As shown in FIG. 4, insertion mechanism housing 202 may be asubstantially cylindrical component having an inner chamber with guideprotrusions 204. The guide protrusions 204 may be a pre-formed aspect onthe interior of insertion mechanism housing 202, or may be a separateguide protrusion sleeve fixedly engaged to the interior proximal end ofthe insertion mechanism housing 202. The guide protrusions 204 slidablyengage manifold guide 220 at pass-throughs 224 on manifold guide ring228. The insertion biasing member 210 initially resides in an energizedstate between the guide protrusions 204 and inner surface of insertionmechanism housing 202 and between the interior proximal end of theinsertion mechanism housing 202 and the manifold guide ring 228 ofmanifold guide 220. Therefore upon activation by the user, as describedfurther hereinafter, the insertion biasing member 210 is caused to bearagainst and exert force upon manifold guide ring 228 of manifold guide220 as the insertion biasing member 210 decompresses and/orde-energizes, causing axial translation in the distal direction of themanifold guide 220 and the components retained within its lower chamber226. Prior to activation, the insertion biasing member 210 is maintainedsubstantially above locking windows 202A in a compressed, energizedstate.

In an alternative embodiment of the insertion mechanism shown in FIG.2B, the insertion mechanism 2000 may include two insertion biasingmembers 2210 A, B. Insertion mechanism 2000 further includes insertionmechanism housing 2202 (shown in transparent view), manifold guide 2220,sterile boot 2250, base 2252, and other components similar to thosedescribed above with reference to insertion mechanism 200. In the twoinsertion biasing members embodiment of the insertion mechanism shown inFIG. 2B, manifold guide ring includes two circular platforms upon whichinsertion biasing member 2210 A, B may bear. Insertion mechanism 2000may function identically to insertion mechanism 200, but may provideadditional insertion force through the use of multiple insertion biasingmembers 2210 A, B. The components and functions of the insertionmechanisms will be described further herein with the understanding thatsimilar or identical components may be utilized for insertion mechanism200, insertion mechanism 2000, and all reasonably understood variationsthereof.

FIG. 5A shows a clip 218, according to one embodiment of the presentinvention. Clip 218 includes aperture 218C on platform 218E throughwhich needle 214 may pass, and release surfaces 218A and lockoutsurfaces 218B of arms 218D. Clip 218 may be made of any number ofresilient materials that are capable of flexing and returning tosubstantially their original form. In an original form, clip 218 mayflex outwards such that arms 218D are not perpendicular with platform218E. Clip 218 resides within clip interface slot 220A of manifold guide220 such that clip 218 is in fixed engagement with manifold guide 220but arms 218D are permitted to flex. In an initial locked stage,retraction biasing member 216 and hub 212 (with connected needle 214)are retained between release surfaces 218A and platform 218E of clip218, and within inner upper chamber 222A of manifold guide 220 (shown inFIG. 4 and FIG. 5B). The needle may pass through aperture 218C of clip218 and manifold guide 220 into septum 230 and manifold 240. Septum 230resides within manifold 240, as shown in FIG. 5C. Manifold 240 furtherhaving a manifold wall which includes a manifold intake 240A through themanifold wall at which the sterile fluid conduit 30 may be connected.This connection is such that the sterility is maintained from the drugcontainer 50 of the drive mechanism 100, through the fluid pathwayconnection 300 and the sterile fluid conduit 30, into sterile manifoldheader 242 of manifold 240 and sterile boot 250 to maintain thesterility of the needle 214, cannula 234, and the fluid pathway untilinsertion into the user for drug delivery.

The operation of the insertion mechanism is described herein withreference to the above components, in view of FIGS. 6A-6C. FIG. 6A showsa cross-sectional view of the insertion mechanism, according to at leastone embodiment of the present invention, in a locked and ready to usestage. Lockout pin(s) 208 are initially positioned within lockoutwindows 202A of insertion mechanism housing 202. In this initialposition, manifold guide ring 228 of manifold guide 220, clip 218, andhub 212 are retained above lockout windows 202A and locking pin(s) 208.In this initial configuration, insertion biasing member 210 andretraction biasing member 216 are each retained in their compressed,energized states.

As shown in FIG. 1B, the lockout pin(s) 208 (not visible) may bedirectly displaced by user depression of the activation mechanism 14. Asthe user disengages any safety mechanisms, such as an optional on-bodysensor 24 (shown in FIG. 1C), the activation mechanism 14 may bedepressed to initiate the drug pump. Depression of the activationmechanism 14 may directly cause translation or displacement of controlarm 40 and directly or indirectly cause displacement of lockout pin(s)208 from their initial position within locking windows 202A of insertionmechanism housing 202. Displacement of the lockout pin(s) 208 permitsinsertion biasing member 210 to decompress and/or de-energize from itsinitial compressed, energized state.

As shown in FIG. 6A, hub ledges 212A maintain retraction biasing member216 in a compressed, energized state between hub 212 and manifold guide220 within inner upper chamber 222A. The hub 212 fixedly engagesproximal end of needle 214 at hub recess 212B. Prior to operation,sealing member 254 may be removed from bottom of base 252 and base 252is placed in contact with the target injection site on the body of theuser. As lockout pin(s) 208 are displaced by the activation mechanism,as described above, and insertion biasing member 210 is permitted toexpand axially in the distal direction (i.e., in the direction of thesolid arrow in FIG. 6A), manifold ring guide 228 is forced by thedecompression and/or de-energizing of the insertion biasing member 210to translate axially in the distal direction to insert the needle 214and cannula 234 into the body of the user. The axial translation of themanifold guide is directed, and maintained in rotational alignment, byinteraction between the guide protrusions 204 of the insertion mechanismhousing 202 and corresponding pass-throughs 224 of the manifold guide220. Release surfaces 218A of clip 218 engage hub 212 and retain theretraction biasing member 216 in a compressed, energized state while themanifold guide 220 travels axially in the distal direction until theclip 218 reaches the end of the guide protrusions 204 where the clip 218is permitted to flex outwards, as will be described further below.

FIG. 6B shows a cross-sectional view of an insertion mechanism in aneedle inserted stage. As shown, sterile boot 250 is permitted tocollapse as the insertion biasing member 210 expands and inserts theneedle 214 and cannula 234 into the body of the user. At this stage,shown in FIG. 6B, needle 218 is introduced into the body of the user toplace the cannula 234 into position for drug delivery. As shown in FIG.6C, upon needle 214 and cannula 234 insertion by operation of theinsertion biasing member 210 as described above, the needle 214 isretracted back (i.e., axially translated in the proximal direction) intothe insertion mechanism housing 202. Manifold guide 220, clip 218, andguide protrusions 204 are dimensioned such that, as the manifold 240substantially bottoms-out on base 252, i.e., reaches its full axialtranslation in the distal direction, the clip 218 escapes the guideprotrusions 204 and is permitted to flex outwards (i.e., in thedirection of the hollow arrows shown in FIG. 6B) to disengage releasesurfaces 218A from hub 212. Upon disengagement of the release surfaces218A from hub 212, retraction biasing member 216 is permitted to expandaxially in the proximal direction (i.e., in the direction of hatchedarrow in FIG. 6C) from its initial compressed, energized state. The clip218 is prevented from retracting or axial translation in the proximaldirection by contact between the lockout surfaces 218B and the distalends of the guide protrusions 204, as shown in FIG. 6C. This lockoutalso prevents axial translation in the proximal direction of themanifold guide 220 and insertion mechanism components that are distal to(i.e., below) the manifold guide ring 228.

Expansion of the retraction biasing member 216 translates hub 212, andneedle 214 to which it is connected, axially in the proximal direction.Ferrule 232 retains cannula 234 inserted within the body of the userthrough base opening 252A. Upon retraction of the needle 214 fromcannula 234, the fluid pathway from manifold header 242 to the body ofthe user through the cannula 234 is opened. As the fluid pathwayconnection is made to the drug container and the drive mechanism isactivated, the fluid drug treatment is forced from the drug containerthrough the fluid pathway connection and the sterile fluid conduit intothe manifold header 242 and through the cannula 234 for delivery intothe body of the user. Accordingly, activation of the insertion mechanisminserts the needle 214 and cannula 234 into the body of the user, andsequentially retracts the needle 214 while maintaining the cannula 234in fluid communication with the body of the user. Retraction of theneedle 214 also opens up the fluid pathway between the manifold header242 and the body of the user through the cannula 234. At the end of thedrug dose delivery, the cannula 234 may be removed from the body of theuser by removal of the drug pump from contact with the user.

A method of operating an insertion mechanism according to the presentinvention includes: removing one or more lockout pins from correspondingone or more locking windows of an insertion mechanism housing, whereinremoval of said lockout pins permits an insertion biasing member toexpand from its initially energized state; driving, by expansion of theinsertion biasing member, a manifold guide axially in the distaldirection to force a needle and a cannula at least partially out of theinsertion mechanism and into the body of a user; permitting outwardsflexion of a clip retained in an upper chamber of the manifold guide,wherein said clip initially retains a hub and a retraction biasingmember in an energized state and wherein flexion disengages one or morerelease surfaces of the clip from contact with a hub thereby permittingexpansion of the retraction biasing member axially in the proximaldirection; and retracting the needle upon retraction of the hub througha fixed connection between the needle and the hub, while maintaining thecannula inserted into the body of the user for fluid delivery.

Certain optional standard components or variations of insertionmechanism 200 or drug pump 10 are contemplated while remaining withinthe breadth and scope of the present invention. For example, upper orlower housings may optionally contain one or more transparent ortranslucent windows 18, as shown in FIGS. 1A-1C, to enable the user toview the operation of the drug pump 10 or verify that drug dose hascompleted. Additionally, the drug pump 10 may contain an adhesive patch26 and a patch liner 28 on the bottom surface of the housing 12. Theadhesive patch 26 may be utilized to adhere the drug pump 10 to the bodyof the user for delivery of the drug dose. As would be readilyunderstood by one having ordinary skill in the art, the adhesive patch26 may have an adhesive surface for adhesion of the drug pump to thebody of the user. The adhesive surface of the adhesive patch 26 mayinitially be covered by a non-adhesive patch liner 28, which is removedfrom the adhesive patch 26 prior to placement of the drug pump 10 incontact with the body of the user. Adhesive patch 26 may optionallyinclude a protective shroud that prevents actuation of the optionalon-body sensor 24 and covers base opening 252A. Removal of the patchliner 28 may remove the protective shroud or the protective shroud maybe removed separately. Removal of the patch liner 28 may further removethe sealing membrane 254 of the insertion mechanism 200, opening theinsertion mechanism to the body of the user for drug delivery.

Similarly, one or more of the components of insertion mechanism 200 anddrug pump 10 may be modified while remaining functionally within thebreadth and scope of the present invention. For example, as describedabove, while the housing of drug pump 10 is shown as two separatecomponents upper housing 12A and lower housing 12B, these components maybe a single unified component. Similarly, while guide protrusions 204are shown as a unified pre-formed component of insertion mechanismhousing 202, it may be a separate component fixedly attached to theinterior surface of the insertion mechanism housing 202. As discussedabove, a glue, adhesive, or other known materials or methods may beutilized to affix one or more components of the insertion mechanismand/or drug pump to each other. Alternatively, one or more components ofthe insertion mechanism and/or drug pump may be a unified component. Forexample, the upper housing and lower housing may be separate componentsaffixed together by a glue or adhesive, a screw fit connection, aninterference fit, fusion joining, welding, ultrasonic welding, and thelike; or the upper housing and lower housing may be a single unifiedcomponent. Such standard components and functional variations would beappreciated by one having ordinary skill in the art and are,accordingly, within the breadth and scope of the present invention.

It will be appreciated from the above description that the insertionmechanisms and drug pumps disclosed herein provide an efficient andeasily-operated system for automated drug delivery from a drugcontainer. The novel embodiments described herein provide integratedsafety features; enable direct user activation of the insertionmechanism; and are configured to maintain the sterility of the fluidpathway. As described above, the integrated safety features includeoptional on-body sensors, redundant lock-outs, automated needleinsertion and retraction upon user activation, and numerous userfeedback options, including visual and auditory feedback options. Thenovel insertion mechanisms of the present invention may be directlyactivated by the user. For example, in at least one embodiment thelockout pin(s) which maintain the insertion mechanism in its locked,energized state are directly displaced from the corresponding lockoutwindows of the insertion mechanism housing by user depression of theactivation mechanism. Alternatively, one or more additional componentsmay included, such as a spring mechanism, which displaces the lockoutpin(s) upon direct displacement of the activation mechanism by the userwithout any intervening steps.

Furthermore, the novel configurations of the insertion mechanism anddrug pumps of the present invention maintain the sterility of the fluidpathway during storage, transportation, and through operation of thedevice. Because the path that the drug fluid travels within the deviceis entirely maintained in a sterile condition, only these componentsneed be sterilized during the manufacturing process. Such componentsinclude the drug container of the drive mechanism, the fluid pathwayconnection, the sterile fluid conduit, and the insertion mechanism. Inat least one embodiment of the present invention, the power and controlsystem, the assembly platform, the control arm, the activationmechanism, the housing, and other components of the drug pump do notneed to be sterilized. This greatly improves the manufacturability ofthe device and reduces associated assembly costs. Accordingly, thedevices of the present invention do not require terminal sterilizationupon completion of assembly. A further benefit of the present inventionis that the components described herein are designed to be modular suchthat, for example, housing and other components of the pump drug mayreadily be configured to accept and operate insertion mechanism 200,insertion mechanism 2000, or a number of other variations of theinsertion mechanism described herein.

Assembly and/or manufacturing of insertion mechanism 200, drug pump 10,or any of the individual components may utilize a number of knownmaterials and methodologies in the art. For example, a number of knowncleaning fluids such as isopropyl alcohol may be used to clean thecomponents and/or the devices. A number of known adhesives or glues maysimilarly be employed in the manufacturing process. Additionally, knownsiliconization fluids and processes may be employed during themanufacture of the novel components and devices. Furthermore, knownsterilization processes may be employed at one or more of themanufacturing or assembly stages to ensure the sterility of the finalproduct.

The insertion mechanism may be assembled in a number of methodologies.In one method, a hub is initially connected to a proximal end of aneedle. The hub and needle are inserted into an inner upper chamber of amanifold guide, wherein a retraction biasing member is maintained in anenergized state between the manifold guide and the hub. The hub, needle,and retraction biasing member are held in this alignment by a clip,wherein the clip is fixedly and flexibly connected to the manifold guideat a clip interface. A cannula is inserted into a manifold and held inplace by a ferrule. A septum is inserted into the manifold at an endopposing the cannula to create a manifold header there-between. Themanifold, septum, cannula, and ferrule are inserted into a lower chamberof the manifold guide such that the needle pierces through the septumand resides within the cannula. The needle extends beyond the distal endof the cannula to provide a piercing tip. A sterile boot is connected tothe manifold, wherein the needle and cannula reside within the sterileboot when the latter is in an expanded configuration.

An insertion spring is inserted into insertion mechanism housing betweenthe housing and one or more guide protrusions extending into theinterior of the housing from the proximal end. The manifold guide,having the components attached thereto as described herein, is insertedinto the insertion mechanism housing such that the guide protrusionsextend through corresponding pass-throughs on a manifold guide ringaspect of the manifold guide. As the manifold guide is translated in theproximal direction, the insertion biasing member is caused to contactthe manifold guide ring and become energized. As translation of themanifold guide and compression of the insertion biasing member reach apoint above one or more lockout windows of the insertion mechanismhousing, one or more corresponding lockout pin(s) may be inserted toretain the manifold guide in this position and the insertion biasingmember in the compressed, energized state.

The distal end of the sterile boot may be positioned and held in fixedengagement with the distal end of the insertion mechanism housing byengagement of the housing with a base. In this position, the sterileboot is in an expanded configuration around the needle and cannula andcreates an annular volume which may be sterile. A fluid conduit may beconnected to the manifold at a manifold intake such that the fluidpathway, when open travels directly from the fluid conduit, through themanifold intake, into the manifold header, and through the cannula uponretraction of the needle. A fluid pathway connection may be attached tothe opposite end of the fluid conduit. The fluid pathway connection, andspecifically a sterile sleeve of the fluid pathway connection, may beconnected to a cap and pierceable seal of the drug container. Theplunger seal and drive mechanism may be connected to the drug containerat an end opposing the fluid pathway connection. A sealing membrane maybe attached to the bottom of the base to close of the insertionmechanism from the environment. The components which constitute thepathway for fluid flow are now assembled. These components may besterilized, by a number of known methods, and then mounted eitherfixedly or removable to an assembly platform or housing of the drugpump.

Manufacturing of a drug pump includes the step of attaching the base ofthe insertion mechanism to an assembly platform or housing of the drugpump. In at least one embodiment, the attachment is such that the baseof the insertion mechanism is permitted to pass-through the assemblyplatform and/or housing to come in direct contact with the body of theuser. The method of manufacturing further includes attachment of thefluid pathway connection, drug container, and drive mechanism to theassembly platform or housing. The additional components of the drugpump, as described above, including the power and control system, theactivation mechanism, and the control arm may be attached, preformed, orpre-assembled to the assembly platform or housing. An adhesive patch andpatch liner may be attached to the housing surface of the drug pump thatcontacts the user during operation of the device.

A method of operating the drug pump includes the steps of: activating,by a user, the activation mechanism; displacing a control arm to actuatean insertion mechanism; and actuating a power and control system toactivate a drive control mechanism to drive fluid drug flow through thedrug pump. The method may further include the step of: engaging anoptional on-body sensor prior to activating the activation mechanism.The method similarly may include the step of: establishing a connectionbetween a fluid pathway connection to a drug container. Furthermore, themethod of operation may include translating a plunger seal within thedrive control mechanism and drug container to force fluid drug flowthrough the drug container, the fluid pathway connection, a sterilefluid conduit, and the insertion mechanism for delivery of the fluiddrug to the body of a user. The method of operation of the insertionmechanism and the drug pump may be better appreciated with reference toFIGS. 6A-6C, as described above.

Throughout the specification, the aim has been to describe the preferredembodiments of the invention without limiting the invention to any oneembodiment or specific collection of features. Various changes andmodifications may be made to the embodiments described and illustratedwithout departing from the present invention. The disclosure of eachpatent and scientific document, computer program and algorithm referredto in this specification is incorporated by reference in its entirety.

What is claimed is:
 1. An insertion mechanism for a drug pump, saidinsertion mechanism comprising: an insertion mechanism housing having aninternal chamber; a base connected to a distal end of the insertionmechanism housing; a manifold guide having a manifold guide ring, themanifold guide being disposed for axial translation within the insertionmechanism housing between an initial configuration and a needleinsertion configuration; one or more insertion biasing members held inan energized state within the internal chamber of the insertionmechanism housing between the insertion mechanism housing and themanifold guide ring when the manifold guide is in the initialconfiguration; a needle having a proximal end; a hub connected to theproximal end of the needle; a retraction biasing member in an energizedstate between the hub and the manifold guide; a manifold; a septum; acannula; an annular space within the manifold between the septum and thecannula defining a manifold header; a sterile boot fixedly connectedbetween the manifold and the base, an interior space being formed withinthe sterile boot between the manifold and the base, the cannula beingdisposed at least partially within the interior space, axial translationof the manifold guide within the insertion mechanism housing between theinitial configuration and the needle insertion configuration translatingthe manifold, the septum, the cannula, the needle, the hub, and theretraction biasing member distally within the insertion mechanismhousing.
 2. The insertion mechanism of claim 1, wherein the sterile bootis compressible or collapsible, axial translation of the manifold guidewithin the insertion mechanism housing between the initial configurationand the needle insertion configuration at least partially compressing orcollapsing the sterile boot as the manifold guide translates from theinitial configuration and the needle insertion configuration.
 3. Theinsertion mechanism of claim 1, wherein the sterile boot includes aproximal end and a distal end, the proximal end of the sterile bootbeing disposed in a fixed engagement with the manifold, and the distalend of the sterile boot being disposed in a fixed engagement with thebase.
 4. The insertion mechanism of claim 1, wherein the cannula isdisposed at least partially about the needle.
 5. The insertion mechanismof claim 4, wherein the base includes a base opening and a sealingmembrane disposed within the base opening, axial translation of themanifold guide within the insertion mechanism housing between theinitial configuration and the needle insertion configuration translatingthe cannula and the needle in a distal direction to pierce the sealingmembrane.
 6. The insertion mechanism of claim 1, further including aclip flexibly engaged with the manifold guide, the clip holding theretraction biasing member in the energized state between the hub and themanifold, axial translation of the manifold guide within the insertionmechanism housing between the initial configuration and the needleinsertion configuration translating the clip holding the retractionbiasing member in the energized state distally within the insertionmechanism housing.
 7. The insertion mechanism of claim 1, wherein themanifold guide has an upper chamber and a lower chamber separated by themanifold guide ring, the manifold being disposed at least partiallywithin the lower chamber of the manifold guide when the manifold guideis disposed in the insertion mechanism housing in both the initialconfiguration and the needle insertion configuration.
 8. The insertionmechanism of claim 1, further comprising at least one lockout pinengaged with the manifold guide ring when the manifold guide is in theinitial configuration to maintain the one or more insertion biasingmembers in the energized state, the at least one lockout pin beingdisplaceable to disengage the manifold guide ring to allow the one ormore insertion biasing members to at least partially de-energize andtranslate the manifold guide distally within the insertion mechanismhousing to the needle insertion configuration.
 9. The insertionmechanism of claim 8, wherein the insertion mechanism housing includesat least one lockout window, the at least one lockout pin extendingthrough the at least one lockout window.
 10. The insertion mechanism ofclaim 9, wherein the insertion mechanism housing includes a sidewall,the at least one lockout window being disposed in the sidewall.
 11. Theinsertion mechanism of claim 8, wherein the manifold guide ring and thehub are disposed proximally to the at least one lockout pin.
 12. A drugdelivery pump with integrated safety features comprising a housing andan assembly platform, wherein an activation mechanism, a drivemechanism, a fluid pathway connection, a power and control system, andthe insertion mechanism according to claim 1 are mounted to the assemblyplatform, the activation mechanism being disposed for selectiveactivation to activate the insertion mechanism.
 13. The drug deliverypump of claim 12, wherein depression of the activation mechanism causesdisplacement of at least one lockout pin engaged with the manifold guidering to allow the one or more insertion biasing members to at leastpartially de-energize and translate the manifold guide distally withinthe insertion mechanism housing.
 14. An insertion mechanism for a drugpump, said insertion mechanism comprising: an insertion mechanismhousing having an internal chamber; a manifold guide having an upperchamber and a lower chamber separated by a manifold guide ring, themanifold guide being disposed for axial translation within the insertionmechanism housing between an initial configuration and a needleinsertion configuration; one or more insertion biasing members held inan energized state within the internal chamber of the insertionmechanism housing between the insertion mechanism housing and themanifold guide ring when the manifold guide is in the initialconfiguration; a clip flexibly engaged with the upper chamber of themanifold guide; a needle having a proximal end; a hub connected to theproximal end of the needle; a retraction biasing member, the clipholding the retraction biasing member in an energized state between thehub and the manifold guide; a manifold at least partially disposedwithin the lower chamber of the manifold guide; a septum; a cannuladisposed at least partially about the needle; and an annular spacewithin the manifold between the septum and the cannula defining amanifold header; axial translation of the manifold guide within theinsertion mechanism housing between the initial configuration and theneedle insertion configuration translating the manifold, the septum, thecannula, the needle, the hub, the clip, and the retraction biasingmember distally within the insertion mechanism housing.
 15. Theinsertion mechanism of claim 14, wherein the manifold is disposed atleast partially within the lower chamber of the manifold guide when themanifold guide is disposed in the insertion mechanism housing in boththe initial configuration and the needle insertion configuration. 16.The insertion mechanism of claim 14, further comprising at least onelockout pin engaged with the manifold guide ring when the manifold guideis in the initial configuration to maintain the one or more insertionbiasing members in the energized state, the at least one lockout pinbeing displaceable to disengage the manifold guide ring to allow the oneor more insertion biasing members to at least partially de-energize andtranslate the manifold guide distally within the insertion mechanismhousing to the needle insertion configuration.
 17. The insertionmechanism of claim 16, wherein the insertion mechanism housing includesat least one lockout window, the at least one lockout pin extendingthrough the at least one lockout window.
 18. The insertion mechanism ofclaim 17, wherein the insertion mechanism housing includes a sidewall,the at least one lockout window being disposed in the sidewall.
 19. Theinsertion mechanism of claim 16, wherein the manifold guide ring and thehub are disposed proximally to the at least one lockout pin.
 20. A drugdelivery pump with integrated safety features comprising a housing andan assembly platform, wherein an activation mechanism, a drivemechanism, a fluid pathway connection, a power control system, and theinsertion mechanism according to claim 14 are mounted to the assemblyplatform, the activation mechanism being disposed for selectiveactivation to activate the insertion mechanism.
 21. The drug deliverypump of claim 20, wherein depression of the activation mechanism causesdisplacement of at least one lockout pin engaged with the manifold guidering to allow the one or more insertion biasing members to at leastpartially de-energize and translate the manifold guide distally withinthe insertion mechanism housing.